DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
This application claims priority to U.S. Provisional Application No. 63/581,073 filed on 09/07/2023 and to U.S. Provisional Application No. 63/484,670 filed on 02/13/2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/24/2024 and 11/21/2024 have been received. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner and all references are considered except where they were lined through.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5-8, 11-12 and 15-16, 18 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Kim et al. (US 2012/0256102 A1).
Claim 1 recites:
“A method of detecting a polypeptide, comprising
(a) providing an affinity reagent comprising an artificial polymer comprising a branched chain that is attached to an affinity moiety and a label;
(b) binding the affinity moiety of the affinity reagent to a polypeptide; and
(c) detecting the label, thereby detecting binding of the affinity reagent to the
polypeptide”.
Regarding claim 1, Kim teaches a method of detecting a polypeptide by providing an affinity reagent that comprise an artificial polymer (Abstract; [0028]; [0071]). Kim further teaches that the artificial polymer comprises a branched chain that is attached to an affinity moiety and a label ([0071]; [0073]; [0076]; [0079]). Kim also teaches binding the affinity moiety of the affinity reagent to a polypeptide ([0051]; [0076]; [0137-0138]; [0141]). And Kim teaches detecting the label, thereby detecting binding of the affinity reagent to the polypeptide ([0028-0029]; [0051]; [0057]; [0086]; [0141]; page 16, claims 18 and 20).
Regarding claim 5, Kim teaches that the artificial polymer is selected from the group consisting of poly(amidoamine) (PAMAM), and PAMAM dendron ([0019]; [0040]; [0054]).
Regarding claim 6, Kim teaches that the affinity moiety is selected from the group consisting of an antibody, an antibody fragment, and a nucleic acid aptamer ([0021]; [0077]).
Regarding claim 7, Kim teaches that the detecting of step (c) comprises detecting an optical signal from the label [0091].
Regarding claim 8, Kim teaches that at least two affinity moieties are attached to the artificial polymer [0026-0027]; page 16, claim 16-17.
Regarding claim 11, Kim teaches that at least two labels are attached to the artificial polymer [0087].
Regarding claim 12, Kim teaches that the detecting of step (c) comprises simultaneously
detecting at least two labels [0087].
Regarding claim 15, Kim teaches that the label is covalently attached to the artificial polymer ([0009]; page 15, claim 1).
Claim 16 recites:
“A molecule, comprising
(a) an artificial polymer comprising a branched chain;
(b) an affinity moiety attached to the artificial polymer; and
(c) a label attached to the artificial polymer”.
Regarding claim 16, Kim teaches a molecule comprising an artificial polymer comprising a branched chain (Abstract; [0071]). Kim teaches an affinity moiety attached to the artificial polymer [0073], [0076]. Kim teaches a label attached to the artificial polymer [0079].
Claim 18 recites:
“A method of making an affinity reagent comprising
(a) providing an artificial polymer comprising a branched chain, wherein at least one
chain of the artificial polymer comprises an alkyne moiety; and
(b) reacting a cysteine of an antibody with the alkyne moiety, thereby covalently
attaching the antibody to the artificial polymer”.
Regarding claim 18, Kim teaches a method of making an affinity reagent ([0135]; [0125]). Kim also teaches providing an artificial polymer comprising a branched chain [0125]. And Kim teaches that at least one chain of the artificial polymer comprises an alkyne moiety ([0073], [0076]). Kim further teaches reacting a cysteine of an antibody with the alkyne moiety, thereby covalently attaching the antibody to the artificial polymer [0142].
Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marcinkowska et al. (Polymers 2018, 10, 187, 1-11).
Claim 19 recites:
“A method of making an affinity reagent comprising
(a) providing an artificial polymer comprising a branched chain, wherein at least one
chain of the artificial polymer comprises a first member of a receptor-ligand pair;
(b) providing an affinity component comprising a second member of the receptor ligand
pair; and
( c) binding the first and second members of the receptor-ligand pair, whereby the
affinity component forms an affinity moiety of the artificial polymer”.
Regarding claim 19, Marcinkowska teaches a method of making an affinity reagent (Abstract, page 2, fourth paragraph, “To verify whether the increase in conjugate selectivity for the specific type of cancer can be achieved, we synthesized a conjugate, in which we combined a protective effect of PAMAM G4 dendrimer, cytotoxic properties of doxorubicin and targeted activity of trastuzumab … Our results obtained for the conjugate PAMAM–dox–trastuzumab showed an increase in the toxic efficiency towards HER-2 positive human breast cancer cells”). Marcinkowska further teaches providing an artificial polymer comprising a branched chain (Abstract, page 2, third paragraph, “we decided to use PAMAM dendrimer not only as a carrier of an anticancer drug but also as a connecting link between the monoclonal antibody trastuzumab and antitumor agents”). And Marcinkowska teaches that at least one chain of the artificial polymer comprises a first member of a receptor-ligand pair (Page 5 of 11, third paragraph, “doxorubicin provides cytotoxic effect”; Figure 1, “3 - PAM AM -dox”). Marcinkowska also teaches providing an affinity component comprising a second member of the receptor ligand pair (Abstract; Page 5 of 11, third paragraph, “trastuzumab provides specificity against human epidermal growth factor receptor 2 (HER-2) that overexpresses in various cancer”; Figure 1, “4 - PAM AM -dox-trastuzumab”). And finally, Marcinkowska teaches binding the first and second members of the receptor-ligand pair so that the affinity component forms an affinity moiety of the artificial polymer (Abstract; page 5 of 11, Figure 1, “3 - PAM AM -dox”; “4 - PAM AM -dox-trastuzumab”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art (PHOSITA) to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-4, 9-10 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2012/0256102 A1) as applied to claim 1 above, and further in view of Mallick et al. (US 2020/0318101 A1)
Regarding claims 2-4, 9-10 and 13-14, the teachings of Kim are previously discussed.
Regarding claim 2, Kim does not teach that the polypeptide is attached to a solid support.
Regarding claim 3, Kim does not teach that the solid support comprises an array of polypeptides.
Regarding claim 4, Kim does not teach that the detecting of the label individually resolves the polypeptide from all other polypeptides in the array of polypeptides.
Regarding claim 9, Kim does not teach that at least two affinity moieties recognize the same
epitope in the polypeptide.
Regarding claim 10, Kim does not teach that at least two affinity moieties recognize different epitopes in the polypeptide.
Regarding claim 13, Kim does not teach further (d) dissociating the affinity moiety of the affinity reagent from the polypeptide, thereby removing the affinity reagent from the polypeptide.
Regarding claim 14, Kim does not teach that the affinity moiety is covalently attached to the artificial Polymer.
Regarding claim 2, Mallick teaches that the polypeptide is attached to a solid support (Abstract; [0039]; [0109]).
Regarding claim 3, Mallick teaches a solid support that comprises an array of polypeptides (Abstract; [0039]).
Regarding claim 4, Mallick teaches that the detecting of the label individually resolves the polypeptide from all other polypeptides in the array of polypeptides [0147].
Regarding claim 9, Mallick teaches the at least two affinity moieties recognize the same epitope in the polypeptide [0081]; [0264]; [0266].
Regarding claim 10, Mallick teaches that at least two affinity moieties recognize different epitopes in the polypeptide [0081]; [0264]; [0266].
Regarding claim 13, Mallick teaches further (d) dissociating the affinity moiety of the affinity reagent from the polypeptide, thereby removing the affinity reagent from the polypeptide [0104].
Regarding claim 14, Mallick teaches that the affinity moiety is covalently attached to the artificial Polymer ([0097], “Detection moieties may be directly or indirectly attached. For example, the detection moiety may be directly covalently attached to the affinity reagent, or may be attached through a linker, or may be attached through an affinity reaction such as complementary nucleic acid tags or a biotin streptavidin pair”).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the polypeptide array of Mallick with the polypeptide detection method of Kim by using artificial polymer affinity reagents because Mallick teaches using its array to characterize the binding patterns of binding reagents which are not specific for a single protein or epitope [0002] and further teaches a method for choosing an affinity reagent which binds to a desired peptide epitope in an array [0004]. A PHOSITA would have had a reasonable expectation of success in combining the methods of Mallick and Kim based on the methods being in the field of detecting polypeptides with affinity reagents.
It would have been obvious for a PHOSITA to combine the polypeptide array of Mallick with the affinity reagents of Kim to characterize the affinity reagents with high sensitivity and specificity.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2012/0256102 A1) in view of Mallick et al. (US 2020/0318101 A1) and Yin et al. (US 2008/0114077 A1)
Claim 17 recites:
“A kit, comprising
(a) a first affinity reagent comprising a first artificial polymer attached to a first
affinity moiety and a first label, wherein the first artificial polymer comprises a branched chain
structure; and
(b) a second affinity reagent comprising a second artificial polymer attached to a
second affinity moiety and a second label, wherein the second artificial polymer comprises the
branched chain structure,
wherein the first affinity moiety recognizes an epitope that is not recognized by the
second affinity moiety and the second affinity moiety recognizes an epitope that is not
recognized by the first affinity moiety”.
Regarding claim 17, Kim teaches an affinity reagent comprising an artificial polymer attached to an affinity moiety and a label (Abstract; [0071]; [0073], [0076]; [0079]).
Kim teaches that the artificial polymer comprises a branched chain structure [0071].
Regarding claim 17, Kim does not teach a first and a second affinity reagents that are conjugated to fluorescent dyes. Kim also does not teach that the first affinity moiety recognizes an epitope that is not recognized by the second affinity moiety and that the second affinity moiety recognizes an epitope that is not recognized by the first affinity moiety.
Regarding claim 17, Mallick teaches a first and second affinity reagents that are conjugated to fluorescent dyes [0100]. Mallick teaches that the first affinity moiety recognizes an epitope that is not recognized by the second affinity moiety and that the second affinity moiety recognizes an epitope that is not recognized by the first affinity moiety [0266].
Regarding claim 17, Yin teaches a kit [0105].
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the polypeptide array of Mallick with the polypeptide detection method of Kim by using artificial polymer affinity reagents because Mallick teaches using its array to characterize the binding patterns of binding reagents which are not specific for a single protein or epitope [0002] and further teaches a method for choosing an affinity reagent which binds a desired peptide epitope in an array [0004]. A skilled artisan would have been further motivated to put the combined methods and reagents of Kim and Mallick into a kit as taught by Yin because Yin noted that such a kit produces storable, shelf-stable reagents for future use [0105]. A PHOSITA would have had a reasonable expectation of success in combining the methods of Yin, Mallick and Kim based on the methods being in the field of detecting polypeptides with affinity reagents.
It would have been obvious for a PHOSITA to combine the polypeptide array of Mallick with the affinity reagents of Kim in one kit as taught by Yin to characterize the affinity reagents with high sensitivity and specificity.
Conclusion
No claims are allowed.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 August 17, 2026
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